Contact information
Type
Scientific
Primary contact
Dr Michael Fenlon
ORCID ID
Contact details
Dental Prosthetics
Room 304
25th Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 7479
michael.fenlon@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013146125
Study information
Scientific title
Acronym
Study hypothesis
That there is no difference between the success of and impact on oral health of patients of lower cobalt chromium distal extension saddle partial dentures and single cantilever distal extension resin bonded bridges.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oral Health
Intervention
Patients suitable for cobalt chromium lower distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups:
1. One group will have the dentures
2. The other will have one or two distal cantilever minimum preparation resin bonded bridges
The success, ongoing problems, maintenance requirements and impact on oral health of the different restorations will be monitored over 5 years.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Fit of dentures
2. Need for adjustment,
3. Acceptability
4. Patient wear of dentures
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2004
Overall trial end date
30/09/2007
Reason abandoned
Lack of funding
Eligibility
Participant inclusion criteria
100 patients attending Guy's Hospital for prostheses for edentulous distal extension saddle areas.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2004
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dental Prosthetics
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary